determine the safety, tolerability, and efficacy of mau868 for the prevention of bk virus infection in kidney transplant recipients

Conditions: BK Virus Nephropathy

Summary: this study is being conducted to determine whether mau868 warrants further clinical development for the prevention of bkv infection in kidney transplant recipients.

this is a non-confirmatory, randomized, placebo-controlled, blinded, proof-of-concept study in kidney transplant recipients. approximately 96 eligible subjects are planned to be randomized 2:1 to receive mau868 or placebo. at least 78 subjects are expected to complete the study. the study will consist of a pre-treatment (screening) consenting period, a 24 week treatment period (consisting of 6 monthly i.v. doses of mau868 or placebo) and a 24 week follow-up period. subjects who complete the study per protocol will attend a total of 16 visits over a period of 48 weeks.

Eligibility criteria:
inclusion criteria; * male or female recipients of a first or second kidney or kidney-pancreas transplant who weigh at least 30 kg and are at least 7 years of age (in the us, 18 years of age or above) at the time of transplantation. * recipients of organs from a heart-beating deceased, non-heart-beating deceased, living unrelated, or human leukocyte antigen (hla)-mismatched living related donor. * recipients who are treated with lymphocyte-depleting induction therapy (e.g., rabbit antithymocyte globulin, alemtuzumab). subjects treated with rabbit antithymocyte globulin must receive a total dose of at least 3 mg/kg. subjects treated with alemtuzumab must receive a total dose of at least 20 mg. * recipients of a kidney with a cold ischemia time (cit) \<36 hours. exclusion criteria: * recipients of organs from identical twins or living, hla-matched, related donors. * abo incompatible or complement-dependent lymphocytotoxic (cdc) crossmatch positive transplant (isolated positive b cell crossmatches are not an exclusion criterion). * recipients who are treated with non-lymphocyte-depleting induction therapy (e.g., basiliximab) or no induction therapy. * recipients who are treated or planned to be treated with mtor inhibitors as part of their initial immunosuppression regimen post-transplantation. * recipients who require antibody-depletion prior to transplantation and in the opinion of the investigator are likely to require antibody-depletion after transplantation. antibody-depleting therapies include but are not necessarily limited to plasmapharesis, immunoadsorption, and ivig. * pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by hcg testing. * current clinical, radiographic, or laboratory evidence of active or latent tuberculosis (tb) or any history, in the opinion of the investigator, that confers a risk of reactivation of tb and precludes the use of conventional immunosuppression. * history of splenectomy or asplenia. * women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing of investigational drug.

Keywords: bkv, renal transplant, renal and kidney transplant